Hot-Button Requests at the FDA as Agency Gets Tough on Menthol Cigarettes

FOIAengine:  Conservative Activists, Law Firms, Non-Profits Signal Competing Agendas

A review of the most recent Freedom of Information Act requests made to the Food and Drug Administration illustrates how political organizations, law firms, news media, and financial firms are actively using FOIA requests to pursue their business and policy objectives. This article describes the insights gained by a review of those requests. The FDA received 1,098 FOIA requests during February, compared with 1,036 during January.

Public Policy FOIA Requests

According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, 25 requests were submitted to the FDA during February by 14 political and non-profit organizations. FOIA requests are often submitted by a political organization to develop information that supports its position on hot-button issues of the day. The FDA’s February requests provide examples.

The ongoing controversy, targeting the FDA’s Center for Tobacco Products over the banning of menthol cigarettes, was the subject of 14 FOIA requests by three conservative organizations: the Functional Government Initiative (8), Protect the Public’s Trust (5), and the Heritage Foundation (1).  

The FDA recommended a ban on menthol-flavored cigarettes and cigars in April 2022. Last fall, the agency delayed finalizing the proposed rule until at least this month.  The FDA’s Center for Tobacco Products is responsible for “reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.”

The Functional Government Initiative filed FOIA requests seeking calendar and travel records of CTP Director Brian King, Office of Science Director Dr. Matthew Farrelly, and Senior Advisor for Health Equity Charlene Le Fauve, along with records of communications from Congresswoman Robin Kelly, D-Ill., an active proponent of the ban on menthol cigarettes. 

FGI describes its mission as “improving the American public’s awareness about the officials, decisions, and priorities of their government. We do this through investigative research, analysis and education.” Chris Stanley, the organization’s Director, has served as Legislative Director to two Republican Senators, Sen. David Vitter, R-La. and Sen. John Neely Kennedy, R-La., and worked in the congressional affairs office of the U.S. Census Bureau during the Trump administration. Peter McGinnis, FGI’s Communications Director was a congressional staffer to Sen. Pat Toomey, R-Pa. 

Protect the Public’s Trust’s FOIA requests seek records regarding communications with the Department of Health and Human Services and the CTP regarding menthol cigarettes, and records related to Triton Distribution and Vapetasia LLC, two manufacturers of e-cigarettes who sued the FDA to overturn its ban of the companies’ products.

PPT describes itself as a “nonpartisan government watchdog organization that seeks to ensure that public officials are all held accountable to the same set of rules, no matter their political party or ideology. To this end, PPT monitors senior officials across the U.S. government for improper and illegal behaviors, self-dealing, and other conflicts of interest, and informs the public to bolster public trust.” 

PPT head Michael Chamberlain has been an active critic of the Biden administration. He led Nevada communications for former President Donald Trump’s 2016 campaign and served for four years as a communication and outreach official at Trump’s Department of Education under Secretary Betsy DeVos. 

The Heritage Foundation is seeking all communication involving the CTP or with any individual that has an “email with the domain name “” or “” that contain the term “zyn,” which is a nicotine product

Heritage is a long-time activist conservative think tank founded in 1973. After the Trump presidency, Heritage hired several former Trump administration officials, including former U.S. vice president Mike Pence. In September 2023, Heritage Foundation co-founder and former president Edwin Feulner publicly endorsed Mike Pence in the 2024 Republican presidential primaries.

Law Firm FOIA Requests

According to FOIAengine, 62 different law firms filed a total of 167 FOIA requests with the FDA during February. 

Kirkland & Ellis LLP filed 31 FOIA requests related to Innova Medical Group’s covid rapid antigen tests, including requests for records and communications related to Timothy Stenzel, who led the FDA diagnostics division during the covid pandemic. Stenzel retired from the FDA at the end of 2023. 

Womble Bond Dickinson (US) LLP filed 15 FOIA requests seeking scientific review documents, submissions, and correspondence relating to E-cigarettes and menthol cigarettes. Womble has represented R.J. Reynolds Vapor Company and R.J. Reynolds Tobacco Company. 

Kelley Drye & Warren LLP submitted 20 requests relating to a variety of drugs (Syfovre, Izervay, Bimzelx, and Darzalex) and drug companies (PolyPeptide Laboratories, Genentech, Inc., Iovance Biotherapeutics Manufacturing, WuXi Advance Therapies, and Him’s). 

Baker & Hostetler LLP submitted ten 10 FOIA requests seeking FDA Health Hazard Evaluations (HHE) relating to several companies, including Wedgewood Village Pharmacy, LLC; Apollo Care; Central Admixture Pharmacy Service, Inc.; Nephtron Sterile Compounding Center LLC; Catalent Indiana, LLC; and Eugia Pharma Specialties. HHE is a tool for classifying a voluntary medical device recall by a firm. The evaluation guides FDA in determining the risk to the public from the defective product and appropriate actions for the firm and the FDA to take to protect public health. As described below, Catalent Indiana and Eugia Pharma are also being watched by financial firms.

Siri & Glimstad LLP submitted nine FOIA requests, including six seeking communications, emails, records, agendas, meeting notes, and annual reports related to the covid vaccine. FOIA requests can be an important early warning of litigation to come. As we reported on January 24 (A Gambit to Allow Covid Vaccine Lawsuits), Siri & Glimstad LLP appears to be seeking an end-around the federal law inoculating the Big Three vaccine makers from covid-vaccine lawsuits. The firm also submitted three requests relating to the FDA’s approval for Neuralink to conduct its first human clinical trial of an implantable brain device.  See our article on Neuralink and Elon Musk (Big Bet on Brain Implants: Elon Musk, Cyborgs, and FOIA.)  As described below, Neuralink is also being targeted by FOIA requests from the news media.

News Media FOIA Requests

Twenty-nine news media companies submitted 72 FOIA requests to the FDA during February requesting information on a wide variety of companies and issues, including Starbucks, Neuralink, weight loss drugs, and drug manufacturing in India. FOIA requests are often a precursor to a news story in subsequent weeks or months, frequently relating unwelcome news about the subject company.

Bloomberg News submitted eight requests relating to Aurobindo and it’s Eugia Pharma Specialties Ltd. subsidiary in India, Neuralink, and menthol cigarettes. As described above, the Biden administration has proposed a ban on menthol cigarettes, and it is receiving significant media attention. 

Reuters submitted nine requests, with seven of them relating to weight loss drugs Ozempic, Wegovy and Rybelsus. See our November article (Morgan & Morgan Targets Weight Control Drugs).

CBS News submitted five requests relating to applesauce lead poisonings, “Neptune’s Fix” products, and requests for information released in previous FOIA requests.

The Wall Street Journal submitted six requests relating to Neuralink, Starbucks and prior FOIA requests.

Also submitting requests were CNBC, CNN, Fortune Magazine, FDA News, the Associated Press, and The New York Times.

 Financial Firm FOIA Requests

Eighteen financial firms submitted 28 FOIA requests for inspection reports and other FDA documents. Requests from financial institutions generally are aimed at identifying positive or negative news about a manufacturer that could affect a company’s stock price. 

Nine financial institutions submitted requests relating to Aurobindo Pharma’s subsidiary Eugia Pharma Specialties Ltd in India and Form 483 inspection reports for an inspection that ran from January 22 to February 2. An FDA Form 483 plant inspection reports is issued by FDA inspectors to firms at the conclusion of an inspection that has found indications that a drug has been or may become adulterated or injurious to health.

These new requests may have been prompted by recent reports of a Form 483 inspection report of Aurobindo’s U.S. subsidiary, Eugia US, that cited 10 observations at the firm’s New Jersey facility during a December inspection.  

FOIA requesters asking about Eugia included Balyasny Asset Management, Bank of America, BNP Paribas, HSBC Securities and Capital Markets (India) Private Limited, IIFL Securities Limited, Investec Capital Services India Pvt Ltd, Macquarie Capital India, Motilal Oswal Financial Services, and Ohm Portfolio Equity Research Private Limited. See our July article (Big Safety Questions About India’s Pharma).

Pharmaceuticals Syfovre and Izervay continued to receive attention from financial firms, including Acuta Capital Partners, Deerfield Management, Iron Triangle Partners, Point72, and UBS. See our June article (Hedge Funds Target Big Pharma). 

Other financial requests sought Adverse Event Reports relating to the drugs Daybue and Ogsiveo, and Form 483 inspection reports relating to Charles River Laboratories LLC , Stericycle Inc., and Brammer Bio MA LLC. An Adverse Event report (FAERS) is a report on adverse reactions and medication error reports associated with the use of drug or biologic products.

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Next from FOIAengine:  Elon Musk’s Neuralink In the spotlight.  

Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law.  FOIAengine is a product of PoliScio Analytics (, a new venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins.  Learn more about FOIAengine hereSign up here to become a beta user of FOIAengine.

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